BACKGROUND/RATIONALE:
Background/Rationale: Heart failure affects 4 to 5 million Americans and is the number one cause of hospitalization in people aged 65 and older. People with heart failure also suffer significant depressive morbidity, with an estimated 11 to 36% meeting criteria for major or minor depression. Comorbid depression in heart failure is associated with greater morbidity, services use, and a two-fold increase in mortality. In 1998, an estimated $5 billion of the $20 billion total cost for heart failure was associated with psychological distress and depression. Several multidisciplinary care management programs have been developed to improve the medical outcomes of heart failure. However, none have addressed the psychological impact of the illness.
Heart failure (HF) is a serious and growing problem in the Veteran and general United States populations. About 5M Americans suffer from HF, and it is the only cardiovascular (CV) illness with increasing prevalence. HF is the most costly CV illness in those 65 and older, primarily due to costly hospitalizations. Within VHA, HF accounts for 2.4% of all hospital admissions and 1.5% of all hospital days. Thus, the improved management of HF is a national VHA priority.
Although several illness management programs for HF have demonstrated efficacy and cost effectiveness, none address one of the most common problems in chronic illness--comorbidity. In the Medicare population, 65% have 2 or more chronic illnesses and 24% have 4 or more, demonstrating that comorbidity is the rule rather than the exception. Single illness management programs often address only part of the problem, and failure to address comorbidities may undermine program effectiveness, even for the targeted illness. Thus, it is time to move from single to multiple disease management programs.
One of the main comorbidities in HF is depression. In longitudinal studies, depressed HF patients become more functionally impaired, are hospitalized more often, and die sooner when compared with HF patients who are not depressed. Depression conferred a two-fold increased mortality risk over two years, even when adjusting for key HF prognostic indicators. The increased morbidity and mortality is not restricted to only those who meet full DSM criteria for a depressive episode. Indeed, depressive symptoms show a linear association with these outcomes. In 1999, it was estimated that $5B of HF's total $20B cost was due to depression or psychological distress. Therefore, to maximize HF outcomes, timely identification and treatment of even sub-clinical levels of depressive symptoms is needed.
Accordingly, the purpose of this study is to compare the effectiveness of a comorbid illness management (CIM) program to a single illness management (SIM) program in HF. The CIM program will address both the emotional and cardiac aspects of HF, including education about emotional adjustment to HF, coping with functional impairment, and education about depression and how to manage it. The SIM program will address only the cardiac aspects of HF. This multi-component intervention makes innovative use of telemedicine. Most of the intervention is conducted by phone. Home monitoring is harnessed to screen for depression and to monitor ongoing depressive morbidity. Given the bidirectional relationship between depression and HF outcomes, we predict that the CIM program will yield not only superior depression outcomes, but also superior HF outcomes.
OBJECTIVE(S):
Objective: This study aims to demonstrate greater effectiveness of a comorbid illness management program that addresses both depressive symptoms and the medical management of heart failure when compared to a standard single illness management heart failure program. We hypothesize that the comorbid illness management program will yield superior psychological AND medical outcomes. We propose that the comorbid illness management program will also lead to better self care in heart failure patients than a single illness management program.
METHODS:
Methods: Study design: This is a two-arm randomized controlled trial. We anticipate recruiting 110-115 patients per treatment arm. Sample characteristics: Veterans aged 45 and older being treated for heart failure at the Iowa City Veteran's Administration Primary Care clinic and the Cardiology clinic and at the Columbia Missouri Veteran's Administration Medical Center will be screened for participation. Inclusion criteria are NYHA Class II, III or IV heart failure, absence of major psychiatric illness such as schizophren; bipolar disorder and substance abuse disorder. Veterans with PTSD will be eligible to participate in the study. Intervention: Participants in the standard illness management program will receive a 12-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. This intervention will be conducted in a combination of home visits and phone visits. They will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness. The comorbid illness management home monitoring will include a twice-monthly screen for depression. Major Variables: The major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure. Main types of analyses: The main study hypotheses will be tested using random mixed effects models comparing the two treatment conditions on main outcomes while controlling for key covariates.
FINDINGS/RESULTS:
No results to report at this time.
IMPACT:
Impact Statement: This novel intervention aims to improve psychological and cardiac health, reduce cost, and improve quality of life for VA patients in the later stages of heart failure. Once implemented, the comorbid illness management model may be applied to other major chronic illnesses in the VA population such as comorbid depression and pulmonary disease or arthritis.
PUBLICATIONS:
Journal Articles
- Klein DM, Turvey CL, Pies CJ. Relationship of coping styles with quality of life and depressive symptoms in older heart failure patients. Journal of Aging and Health. 2007; 19(1): 22-38.
